PD26-09 TRANSURETHRAL WATER VAPOR THERAPY FOR BPH; 1-YEAR CLINICAL RESULTS OF THE FIRST-IN-MAN AND REZūM® I CLINICAL TRIALS USING THE REZūM® SYSTEM

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2014PD26-09 TRANSURETHRAL WATER VAPOR THERAPY FOR BPH; 1-YEAR CLINICAL RESULTS OF THE FIRST-IN-MAN AND REZūM® I CLINICAL TRIALS USING THE REZūM® SYSTEM Christopher Dixon, Edwin Rijo Cedeno, Dalibor Pacik, Gabriel Varga, Viteslav Vit, and Lance Mynderse Christopher DixonChristopher Dixon More articles by this author , Edwin Rijo CedenoEdwin Rijo Cedeno More articles by this author , Dalibor PacikDalibor Pacik More articles by this author , Gabriel VargaGabriel Varga More articles by this author , Viteslav VitViteslav Vit More articles by this author , and Lance MynderseLance Mynderse More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2096AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Rezūm® System is a transurethral device being developed for the treatment of BPH. It is fundamentally different than earlier devices because it is based on the principle of phase-change, convective heating using steam. This allows rapid tissue ablation, short procedure times and “compartmentalization” of the vapor to the transition zone. The objective was to assess clinical outcomes using a range of energy in the First-In-Man trial (FIM) followed by a standardized energy dose for the Rezūm I trial. METHODS Ethics Committee approvals from 2 centers and informed consents from 30 men were obtained. Both trials used the same entry criteria. The FIM trial used energy ranging from 190 to 289 calories per injection, whereas, the Rezūm I trial used a standardized dose of 208 calories per injection. One to 3 injections per lobe were delivered, including the median lobe, if present. Standard outcome measures including IPSS, QOL, Qmax and PVR were used. MRI’s with 3D rendering were performed at 1wk, 1, 3, and 6 months post treatment. Safety was assessed by serial MRI’s and adverse event reporting. RESULTS Energy time per injection ranged from 7-10 seconds and mean procedure time was 8 minutes (range 2-23). Mean baseline IPSS (n=30) was 23.0 (range 15-35) improving to 13.2, 8.7, 8.3 and 10.7 at one (n=30), three (n=28), six months (n=28), and one year (n=24) respectively. Mean baseline QOL (n=30) was 4.3 improving to 2.3, 1.5, 1.5 and 1.8 at one (n=30), three (n=28), six months (n=28), and one year (n=24) respectively. Mean baseline Qmax (n=30) was 8.4cc/sec improving to 10, 12.7, 12.1 and 12.5cc/sec at one (n=30), three (n=28), six months (n=28), and one year (n=23) respectively. Mean baseline PVR (n=28) was 71cc, remaining stable at 1 week, and improving to 39cc at one year (n=23). Serial MRI’s validated the principle of convective heating. Thermal lesions resolved by 93%, and total prostate volume was reduced by 26% at 3 months post procedure. Adverse events included transient retention, mild dysuria and hematuria. There were no rectal injuries, de novo incontinence or sexual function side effects reported. CONCLUSIONS Favorable improvement was seen in all clinical outcome parameters. The MRI data validated the principle of convective heating and demonstrated lesion resolution and prostate volume reduction. Adverse events were mild. These data suggest favorable clinical outcomes and the safe delivery of water vapor to the transition zone. Conduction of a multi-center, controlled, pivotal trial is supported. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e762 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Christopher Dixon More articles by this author Edwin Rijo Cedeno More articles by this author Dalibor Pacik More articles by this author Gabriel Varga More articles by this author Viteslav Vit More articles by this author Lance Mynderse More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...